Primary outcomeMean· 2 months
The Jankovic Blepharospasm Rating Scale at 2 Month
| Group | Value (units on a scale) |
|---|---|
| 0.05% AH-8 | 6 |
| 0.025% AH-8 | 7 |
| Placebo | 4.33 |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataAcetyl Hexapeptide-8 for Blepharospasm
This trial was stopped early.
The registry gives no reason.
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Phase 2
- Enrollment
- 8 participants (actual)
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS) · Nih
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- Nov 2012
- Primary completion
- May 2015
- Completion
- May 2015
- First posted
- 17 Dec 2012 (estimated)
- Last update posted
- 10 Nov 2016 (estimated)
- Conditions
- Focal Dystonia
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20122013201420152016
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Background: \- Blepharospasm is caused by excessive contraction of the muscles that close the eye. One treatment is botulinum neurotoxin (BoNT), which works by weakening those muscles. Like BoNT, acetyl hexapeptide-8 (AH-8) works to weaken the muscles, but is available as a skin cream. AH-8 is the active ingredient in a number of cosmetic creams used to treat wrinkles. Researchers thought that AH-8 cream could be used to treat blepharospasm, but the original dose studied was not very effective. They want to try a higher dose of AH-8 in a cream to see if it can be a more effective treatment. Objectives: \- To see if AH-8 cream can improve the symptoms of blepharospasm. Eligibility: \- Individuals at least 18 years of age who have blepharospasm that is severe enough to require treatment. Design: * This study will involve up to eight study visits. * Participants will be screened with a physical exam and medical history. They will answer questions about their symptoms. They will also have a blink test to see how severe the blepharospasm is. At this visit, participants will receive one of three types of cream. One cream will have a low dose of AH-8, one will have a higher dose of AH-8, and the other will be a placebo (no AH-8). * One month later, participants will have a followup visit, with tests similar to the first visit. They will also receive more of the cream. * One month later, participants will have another visit with the same tests. They will be videotaped at this visit to study their facial movements. Those who have responded to the treatment will continue to use the cream. Those who have not responded will be offered the chance to have BoNT injections, and will stop taking the cream. * One month later, participants who had BoNT injections will have a final visit to check for possible side effects. Those who continued to take the cream will continue on the study. * The fifth and sixth visits will involve the same tests as before. At the seventh visit, remaining participants will be offered the chance to have BoNT injections, and will stop taking the cream. * The final visit will check for any side effects from the cream or the injections.
Interventions
- Topical acetyl hexapeptide-8Drug
- PlaceboDrug
Arms3
Active comparator
0.05% AH-8
Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the brand name, Argireline.
Active comparator
0.025% AH-8
Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the brand name, Argireline.
Placebo comparator
Placebo
Participants in the Placebo arm received the placebo.
Primary outcomes1
Outcomes the sponsor listed as primary.
The Jankovic Blepharospasm Rating Scale at 2 Month
Time frame · 2 months
Registry description
The Jankovic Blepharospasm Rating Scale (JBRS) at 2 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally "blind" due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8.
Secondary outcomes(6)
The Jankovic Blepharospasm Rating Scale at 1 Month
Time frame · 1 month
Registry description
The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 1 month from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally "blind" due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8.
The Blepharospasm Disability Scale at 1 Month
Time frame · 1 month
Registry description
The Blepharospasm Disability Scale (BDS) was measured at 1 month from the start of the study drug or placebo. The BDS is a scale which measures the impact of blepharospasm on the activities of daily living, i.e., need to wear sunglasses (1 or 2) and the impact on the following activities: driving (1 to 5), reading (1 to 3), watching tv (1 to 3), watching movies (1 to 3), shopping (1 to 3), walking about (1 to 4) and housework or job (1 to 3). Patients self-report disability in all areas for a total score between 0 to 26, where 0 indicates no symptoms and 26 indicates severe disability.
The Blepharospasm Disability Scale at 2 Months
Time frame · 2 months
Registry description
The Blepharospasm Disability Scale (BDS) was measured at 2 months from the start of the study drug or placebo. The BDS is a scale which measures the impact of blepharospasm on the activities of daily living, i.e., need to wear sunglasses (1 or 2) and the impact on the following activities: driving (1 to 5), reading (1 to 3), watching tv (1 to 3), watching movies (1 to 3), shopping (1 to 3), walking about (1 to 4) and housework or job (1 to 3). Patients self-report disability in all areas for a total score between 0 to 26, where 0 indicates no symptoms and 26 indicates severe disability.
The Jankovic Blepharospasm Rating Scale at 3 Months
Time frame · 3 months
Registry description
The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 3 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally "blind" due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8.
The Jankovic Blepharospasm Rating Scale at 6 Months
Time frame · 6 months
Registry description
The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 6 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally "blind" due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8.
The Jankovic Blepharospasm Rating Scale at 7 Months
Time frame · 7 months
Registry description
The Jankovic Blepharospasm Rating Scale (JBRS) was measured at 7 months from the start of the study drug or placebo. The JBRS is a clinical scale measuring the severity and frequency of blepharospasm. Severity and frequency are rated on a 5-point scales ranging from 0 to 4, where 0 indicates no symptoms and 4 indicates the most severe or frequent symptoms (Severity: severe, incapacitating spasm of eyelids and possibly other facial muscles; Frequency: Functionally "blind" due to persistent eye closure (blepharospasm) more than 50% of the waking time.) A total score is obtained by adding the severity and frequency subscale scores with total scores ranging from 0 to 8.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(6)
Secondary outcomeMean· 1 month
The Jankovic Blepharospasm Rating Scale at 1 Month
| Group | Value (units on a scale) |
|---|---|
| 0.05% AH-8 | 6.66 |
| 0.025% AH-8 | 5.5 |
| Placebo | 5 |
Secondary outcomeMean· 1 month
The Blepharospasm Disability Scale at 1 Month
| Group | Value (units on a scale) |
|---|---|
| 0.05% AH-8 | 16.33 |
| 0.025% AH-8 | 16.5 |
| Placebo | 14.66 |
Secondary outcomeMean· 2 months
The Blepharospasm Disability Scale at 2 Months
| Group | Value (units on a scale) |
|---|---|
| 0.05% AH-8 | 18.5 |
| 0.025% AH-8 | 15 |
| Placebo | 13.33 |
Secondary outcomeMean· 3 months
The Jankovic Blepharospasm Rating Scale at 3 Months
| Group | Value (units on a scale) |
|---|---|
| 0.05% AH-8 | 6.5 |
| 0.025% AH-8 | 3 |
| Placebo | 2.33 |
Secondary outcomeNumber· 6 months
The Jankovic Blepharospasm Rating Scale at 6 Months
| Group | Value (units on a scale) |
|---|---|
| 0.05% AH-8 | 8 |
| 0.025% AH-8 | 6 |
| Placebo | 0 |
Secondary outcomeNumber· 7 months
The Jankovic Blepharospasm Rating Scale at 7 Months
| Group | Value (units on a scale) |
|---|---|
| 0.05% AH-8 | 8 |
| 0.025% AH-8 | not posted |
| Placebo | 2 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 0.05% AH-8Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline. Topical acetyl hexapeptide-8 | – | 1 / 3 | 2 / 3 |
| 0.025% AH-8Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline. Topical acetyl hexapeptide-8 | – | 0 / 2 | 0 / 2 |
| PlaceboParticipants in the Placebo arm received the placebo. Topical acetyl hexapeptide-8 | – | 1 / 3 | 2 / 3 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
* INCLUSION CRITERIA:
* Primary blepharospasm diagnosed or confirmed by a Movement Disorders Neurologist, confirmed at the initial visit by a study investigator.
* Individuals off BoNT therapy for at least 4 months will be eligible for this study.
* Severity prompting need for treatment as determined by clinical judgment
* At least a score of 4 on the JBRS
* At least a score of 8 on the BDS
* Duration of symptoms of at least 1 year, without subjective active progression by patient report
* Concomitant therapy allowed, except injectable BoNT therapy, provided the doses remain stable throughout the study period
* Adult patients (\> 18)
EXCLUSION CRITERIA:
* Blepharospasm associated with generalized or extensive regional dystonia
* Medical condition impairing the patient's ability to comply with the study protocol or to perform daily applications of the cream as instructed as judged by recruiting physician
* Local eyelid pathology precluding topical treatment
* Received BoNT within 4 months prior to enrollment
* Continued benefit from a prior BoNT injection (by history and self assesment) Current use of cosmetic wrinkle creams
* Prior myectomy procedure excluded
* Pregnant women excluded. Barrier contraception will be used throughout the study for women of childbearing age, as it is not known how the use of hormonal contraceptives may interact with the study substance. Menopausal status will be determined by the CNS IRB criteria. In women of childbearing potential, a pregnancy test will be performed at the initial visit and periodically every 2 months for the duration of the study. Barrier contraception will be deemed necessary for the duration of the study and none after.
* Use of other treatments for blepharospasm allowed if the doses remain constant
* Allergy/sensitivity to study substance or vehicle.
* Active drug or alcohol abuse or dependence
* Patients with uncontrolled co-existing medical conditions: uncontrolled systemic hypertension with values above 170/100; active heart disease needing immediate intervention; active respiratory disease needing intervention; known or observed eye pathology; any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician
* Cognitive inability to independently use cr(SqrRoot)(Registered Trademark)me use safely.
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