DystoniaPhase 2NCT02107261

Incobotulinum Toxin A (Xeomin®) As A Treatment For Focal Task-Specific Dystonia Of The Musician's Hand

A Phase 2 study testing incobotulinumtoxin A in people with Dystonia, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Dystonia
What is being tested?: incobotulinumtoxin A
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21 participants
Where: 2 sitesUnited States
Study dates: Mar 2014to 27 Jan 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with focal task-specific dystonia of one or both hands, selectively triggered by performance on a musical instrument.
Patients must have been evaluated by Dr. Frucht at the Movement Disorders Division of Mount Sinai Medical Center as part of their clinical care.
Patients whose performance on an instrument is directly linked to their occupation.
Patients must be between the ages of 18 and 80.
Impairment in musical performance must be visible and demonstrable.

Who cannot join

Patients whose dystonia is not severe enough to interfere with musical performance in the opinion of a skilled examiner.
Patients with unstable medical conditions or psychiatric conditions.
Patients with a medical condition that precludes them from receiving BoNT injections.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

NYU Langone Health
New York, New York, 10017
Icahn School of Medicine at Mount Sinai
New York, New York, 10029

Other trials in United States

About this study

Official title: A Placebo-Controlled, Double-Blind, Randomized, Cross Over Pilot Study Of The Efficacy And Tolerability Of Incobotulinum Toxin A (Xeomin®) As A Treatment For Focal Task-Specific Dystonia Of The Musician's Hand

The investigational drug being studied in this protocol is Incobotulinumtoxin A (Xeomin®). Botulinum toxin (BoNT) prevents the release of the acetylcholine from peripheral nerves, inhibiting muscle contractions. BoNT is effective in relaxing overactive muscles. In musician's dystonia, the ability to reduce abnormally overactive muscles in the hand can be critical for the musical professional to continue his or her career. With the use of EMG/electrical stimulation and/or ultrasound guidance, the injector can precisely localize the individual muscles that are affected in this condition with great accuracy. Prior studies have shown that BoNT injections produce beneficial effects in forearm muscles, and less effect in shoulder or proximal arm muscles.

Possible risks in treating patients with BoNT include excessive weakness of the injected muscles. The drug may also affect non-targeted muscles. However these risks will be minimized during the screening period by carefully targeting the affected muscles and by administering low doses of BoNT. Small booster doses may be given at follow up visit (2, 4, 14 and 16-weeks after the primary injection date) if the initial injection was insufficient to produce sufficient efficacy in relief of the focal dystonia and did not produce excess weakness of the targeted muscle.

Conditions: Dystonia
Being tested: incobotulinumtoxin A, Placebo
Keywords: Musician's Dystonia
Medical subject headings: Dystonia, Dystonia, Focal, Task-Specific

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

incobotulinumtoxin ADrug
Also called Xeomin
Incobotulinumtoxin A is being used on average doses between 10U and 30 Units per subject, but at no time will any subject receive over 100 Units. Each study visit, the assessing physician will select the muscles and the amounts of medication to be injected.
PlaceboDrug
matching placebo

Study groups in NCT02107261
Study group	Role	What they receive
Placebo Then Botulinum Toxin	Active comparator	Placebo dose first does then boosters at week 2 and week 4 then 4 weeks washout, then Incobotulinumtoxin A first dose, with boosters at 2 week and week 4. Receives: Drug: incobotulinumtoxin A; Drug: Placebo
Incobotulinumtoxin A Then Placebo	Active comparator	Incobotulinumtoxin A dose first does then boosters at week 2 and week 4 then 4 weeks washout, then Placebo first dose, with boosters at 2 week and week 4. Receives: Drug: incobotulinumtoxin A; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Physician Global Perception of Change - Blinded Rater 1
The principal outcome measure was improvement in musical performance, measured by blinded rater, using physician global perception of change at post treatment compared to at 8 weeks. Categories are very much improved, much improved, minimal improved, no change, and minimal worse.
Measured: at visit 4 (week 8)
Physician Global Perception of Change - Blinded Rater 2
The principal outcome measure was improvement in musical performance, measured by blinded rater, using physician global perception of change at post treatment compared to at 8 weeks. Categories are very much improved, much improved, minimal improved, no change, and minimal worse.
Measured: at visit 4 (week 8)
Rating of Overall Musical Performance - Blinded Rater 1
Rating of overall musical performance based on comparison to baseline video at week 8.
Rating from +3, very much improved to -3, very much worse. Higher score indicates more improvement.
Measured: baseline and at 8 weeks
Rating of Overall Musical Performance - Blinded Rater 2
Rating of overall musical performance based on comparison to baseline video at week 8.
Best Overall Musical Performance on 7 point scale from +3 Very much improved to -3 Very much worse. Higher score indicates more improvement.
Measured: baseline and week 8
Quantitative MIDI Analysis Comparison
The principal outcome measure will be improvement in musical performance, measured by self-rated questionnaire, quantitative Musical Instrument Digital Interface (MIDI) analysis and blinded high speed video analysis post treatment compared to baseline and 24 weeks.
Measured: baseline at 24 weeks
Blinded High Speed Video Analysis Comparison
The principal outcome measure will be improvement in musical performance, measured by self-rated questionnaire, quantitative MIDI analysis and blinded high speed video analysis post treatment compared to baseline and 24 weeks.
Measured: baseline and at 24 weeks

Secondary outcomes (3)

Change in Perceived Stress Scale (PSS)
Patient reported outcomes measured by questionnaires that address adverse events and the impact of quality of life using the perceived stress scale. A 10-item questionnaire, each item scored 0 (never) to 4 (very often), full scale from 0-40, with higher score indicating higher perceived stress. the more often the person perceives stress Change in PSS at week 8 compared to baseline
Measured: baseline and at 8 weeks
Change in Medical Research Council (MRC) Scale
Motor strength using a dynamometer of the finger/wrist/elbow flexors to document any treatment induced weakness.
Scale from 0-4, higher score indicates poorer health outcomes.
Measured: baseline and at 8 weeks
Change in Motor Strength Comparison
Motor strength tested using a dynamometer to document any weakness the treatment may produce as compared to the baseline visit and 8 weeks.
Dynamometer (DYN) - is a mechanical device that measures the pounds of force that a muscle exerts, Grip - a device that measures grip strength, and finger flexors digit 2 and 3 (FF d2-3). These measures are the amount of lbs of force exert. The higher number is the highest exerted out of 3 tries.
Measured: baseline and at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 201427 Jan 2020

First posted8 Apr 2014 (estimated)
Study startMar 2014
Primary completion27 Jan 2020
Study completion27 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (13)Papers the sponsor has linked to this study.
Other trials for DystoniaStudies of the same condition, open and under way.
More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02107261
Sponsor's protocol ID: GCO 13-1679
Status last verified: Apr 2023
First submitted: 26 Mar 2014
Last updated: 11 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Jankovic J, Ashoori A. Movement disorders in musicians. Mov Disord. 2008 Oct 30;23(14):1957-65. doi: 10.1002/mds.22255.
PubMed 18785647
Pullman SL, Hristova AH. Musician's dystonia. Neurology. 2005 Jan 25;64(2):186-7. doi: 10.1212/01.WNL.0000157497.08500.c1. No abstract available.
PubMed 15668411
Altenmuller E. Focal dystonia: advances in brain imaging and understanding of fine motor control in musicians. Hand Clin. 2003 Aug;19(3):523-38, xi. doi: 10.1016/s0749-0712(03)00043-x.
PubMed 12945651
Frucht SJ, Fahn S, Greene PE, O'Brien C, Gelb M, Truong DD, Welsh J, Factor S, Ford B. The natural history of embouchure dystonia. Mov Disord. 2001 Sep;16(5):899-906. doi: 10.1002/mds.1167.
PubMed 11746620
Elbert T, Pantev C, Wienbruch C, Rockstroh B, Taub E. Increased cortical representation of the fingers of the left hand in string players. Science. 1995 Oct 13;270(5234):305-7. doi: 10.1126/science.270.5234.305.
PubMed 7569982
Munte TF, Altenmuller E, Jancke L. The musician's brain as a model of neuroplasticity. Nat Rev Neurosci. 2002 Jun;3(6):473-8. doi: 10.1038/nrn843.
PubMed 12042882
Altenmuller E, Baur V, Hofmann A, Lim VK, Jabusch HC. Musician's cramp as manifestation of maladaptive brain plasticity: arguments from instrumental differences. Ann N Y Acad Sci. 2012 Apr;1252:259-65. doi: 10.1111/j.1749-6632.2012.06456.x.
PubMed 22524368
Schmidt A, Jabusch HC, Altenmuller E, Hagenah J, Bruggemann N, Hedrich K, Saunders-Pullman R, Bressman SB, Kramer PL, Klein C. Dominantly transmitted focal dystonia in families of patients with musician's cramp. Neurology. 2006 Aug 22;67(4):691-3. doi: 10.1212/01.wnl.0000230148.00035.f9.
PubMed 16924027
Altenmuller E, Jabusch HC. Focal dystonia in musicians: phenomenology, pathophysiology, triggering factors, and treatment. Med Probl Perform Art. 2010 Mar;25(1):3-9.
PubMed 20795373
Schuele S, Jabusch HC, Lederman RJ, Altenmuller E. Botulinum toxin injections in the treatment of musician's dystonia. Neurology. 2005 Jan 25;64(2):341-3. doi: 10.1212/01.WNL.0000149768.36634.92.
PubMed 15668436
Pullman SL, Greene P, Fahn S, Pedersen SF. Approach to the treatment of limb disorders with botulinum toxin A. Experience with 187 patients. Arch Neurol. 1996 Jul;53(7):617-24. doi: 10.1001/archneur.1996.00550070055012.
PubMed 8929169
Peterson DA, Berque P, Jabusch HC, Altenmuller E, Frucht SJ. Rating scales for musician's dystonia: the state of the art. Neurology. 2013 Aug 6;81(6):589-98. doi: 10.1212/WNL.0b013e31829e6f72. Epub 2013 Jul 24.
PubMed 23884039
Chang FC, Frucht SJ. Motor and Sensory Dysfunction in Musician's Dystonia. Curr Neuropharmacol. 2013 Jan;11(1):41-7. doi: 10.2174/157015913804999531.
PubMed 23814536

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Limb Dystonia, Idiopathic Dystonia
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
Active, not recruitingPhase 1/2
Deep Brain Stimulation Surgery for Focal Hand Dystonia
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All Dystonia trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Placebo-Controlled, Double-Blind, Randomized, Cross Over Pilot Study Of The Efficacy And Tolerability Of Incobotulinum Toxin A (Xeomin®) As A Treatment For Focal Task-Specific Dystonia Of The Musician's Hand
ClinicalTrials.gov ID: NCT02107261
Acronym / sponsor ID: GCO 13-1679
Conditions: Dystonia
Keywords: Musician's Dystonia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Icahn School of Medicine at Mount SinaiUniversity, hospital or other
Collaborators: Merz North America, Inc.
Study start: Mar 2014
Primary completion: 27 Jan 2020 (actual)
Study completion: 27 Jan 2020 (actual)
First posted: 8 Apr 2014 (estimated)
Results: Posted 11 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo Then Botulinum Toxin	Active comparator	Drug: incobotulinumtoxin A, Drug: PlaceboPlacebo dose first does then boosters at week 2 and week 4 then 4 weeks washout, then Incobotulinumtoxin A first dose, with boosters at 2 week and week 4.
Incobotulinumtoxin A Then Placebo	Active comparator	Drug: incobotulinumtoxin A, Drug: PlaceboIncobotulinumtoxin A dose first does then boosters at week 2 and week 4 then 4 weeks washout, then Placebo first dose, with boosters at 2 week and week 4.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients with focal task-specific dystonia of one or both hands, selectively triggered by performance on a musical instrument.
Patients must have been evaluated by Dr. Frucht at the Movement Disorders Division of Mount Sinai Medical Center as part of their clinical care.
Patients whose performance on an instrument is directly linked to their occupation.
Patients must be between the ages of 18 and 80.
Impairment in musical performance must be visible and demonstrable.

Key exclusion criteria (3 listed)

Patients whose dystonia is not severe enough to interfere with musical performance in the opinion of a skilled examiner.
Patients with unstable medical conditions or psychiatric conditions.
Patients with a medical condition that precludes them from receiving BoNT injections.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
incobotulinumtoxin AAlso: XeominIncobotulinumtoxin A is being used on average doses between 10U and 30 Units per subject, but at no time will any subject receive over 100 Units. Each study visit, the assessing physician will select the muscles and the amounts of medication to be injected.	Drug	Incobotulinumtoxin A Then Placebo, Placebo Then Botulinum Toxin
Placebomatching placebo	Drug	Incobotulinumtoxin A Then Placebo, Placebo Then Botulinum Toxin

Primary outcome

Physician Global Perception of Change - Blinded Rater 1
Time frame: at visit 4 (week 8)
The principal outcome measure was improvement in musical performance, measured by blinded rater, using physician global perception of change at post treatment compared to at 8 weeks. Categories are very much improved, much improved, minimal improved, no change, and minimal worse.
Physician Global Perception of Change - Blinded Rater 2
Time frame: at visit 4 (week 8)
The principal outcome measure was improvement in musical performance, measured by blinded rater, using physician global perception of change at post treatment compared to at 8 weeks. Categories are very much improved, much improved, minimal improved, no change, and minimal worse.
Rating of Overall Musical Performance - Blinded Rater 1
Time frame: baseline and at 8 weeks
Rating of overall musical performance based on comparison to baseline video at week 8. Rating from +3, very much improved to -3, very much worse. Higher score indicates more improvement.
Rating of Overall Musical Performance - Blinded Rater 2
Time frame: baseline and week 8
Rating of overall musical performance based on comparison to baseline video at week 8. Best Overall Musical Performance on 7 point scale from +3 Very much improved to -3 Very much worse. Higher score indicates more improvement.
Quantitative MIDI Analysis Comparison
Time frame: baseline at 24 weeks
The principal outcome measure will be improvement in musical performance, measured by self-rated questionnaire, quantitative Musical Instrument Digital Interface (MIDI) analysis and blinded high speed video analysis post treatment compared to baseline and 24 weeks.
Blinded High Speed Video Analysis Comparison
Time frame: baseline and at 24 weeks
The principal outcome measure will be improvement in musical performance, measured by self-rated questionnaire, quantitative MIDI analysis and blinded high speed video analysis post treatment compared to baseline and 24 weeks.

3 secondary outcomes

Change in Perceived Stress Scale (PSS)
Time frame: baseline and at 8 weeks
Change in Medical Research Council (MRC) Scale
Time frame: baseline and at 8 weeks
Change in Motor Strength Comparison
Time frame: baseline and at 8 weeks

Results and safety

Results posted to the registry on 11 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Then Botulinum Toxin	11	11
Incobotulinumtoxin A Then Placebo	10	10

Primary outcome: Physician Global Perception of Change - Blinded Rater 1

Time frame: at visit 4 (week 8). Count of participants. Unit: Participants

Measure	Placebo n = 11	Incobotulinum Toxin Injection n = 9
Very much improved	1	1
Much Improved	1	4
Minimally Improved	3	3
No Change	3	0
Minimally Worse	3	1

Population analysed: Data not collected for one participant. Data results for Week 8 before crossover treatment.

Primary outcome: Physician Global Perception of Change - Blinded Rater 2

Time frame: at visit 4 (week 8). Count of participants. Unit: Participants

Measure	Placebo n = 11	Incobotulinum Toxin Injection n = 9
Very much improved	0	0
Much Improved	1	2
Minimal Improved	4	5
No Change	3	1
Minimal Worse	3	1

Population analysed: Data not collected for one participant. Data results for Week 8 before crossover treatment.

Primary outcome: Rating of Overall Musical Performance - Blinded Rater 1

Time frame: baseline and at 8 weeks. Count of participants. Unit: Participants

Measure	Placebo n = 11	XEOMIN n = 9
+3 Very much improved	0	1
+2 Much improved	2	2
+1 Minimally improved	0	3
0 No change	5	2
-1 Minimal worse	4	1
-2 Much worse	0	0
-3 Very much worse	0	0

Population analysed: Data not collected for one participant. Data results for Week 8 before crossover treatment.

Primary outcome: Rating of Overall Musical Performance - Blinded Rater 2

Time frame: baseline and week 8. Count of participants. Unit: Participants

Measure	Placebo n = 11	Incobotulinum Toxin Injection n = 9
+3 Very much improved	0	0
+2 Much Improved	3	2
+1 Minimally Improved	0	4
0 No Change	5	2
-1 Minimally Worse	3	1
-2 Much worse	0	0
-3 Very much worse	0	0

Population analysed: Data not collected for one participant. Data results for Week 8 before crossover treatment.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 20 (0%)	12 of 20 (60%)	0 of 20
Incobotulinum Toxin Injection	0 of 21 (0%)	7 of 21 (33.3%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18785647Jankovic J, Ashoori A. Movement disorders in musicians. Mov Disord. 2008 Oct 30;23(14):1957-65. doi: 10.1002/mds.22255.
Background: PubMed 15668411Pullman SL, Hristova AH. Musician's dystonia. Neurology. 2005 Jan 25;64(2):186-7. doi: 10.1212/01.WNL.0000157497.08500.c1. No abstract available.
Background: PubMed 12945651Altenmuller E. Focal dystonia: advances in brain imaging and understanding of fine motor control in musicians. Hand Clin. 2003 Aug;19(3):523-38, xi. doi: 10.1016/s0749-0712(03)00043-x.
Background: PubMed 11746620Frucht SJ, Fahn S, Greene PE, O'Brien C, Gelb M, Truong DD, Welsh J, Factor S, Ford B. The natural history of embouchure dystonia. Mov Disord. 2001 Sep;16(5):899-906. doi: 10.1002/mds.1167.
Background: PubMed 7569982Elbert T, Pantev C, Wienbruch C, Rockstroh B, Taub E. Increased cortical representation of the fingers of the left hand in string players. Science. 1995 Oct 13;270(5234):305-7. doi: 10.1126/science.270.5234.305.
Background: PubMed 12042882Munte TF, Altenmuller E, Jancke L. The musician's brain as a model of neuroplasticity. Nat Rev Neurosci. 2002 Jun;3(6):473-8. doi: 10.1038/nrn843.
Background: PubMed 22524368Altenmuller E, Baur V, Hofmann A, Lim VK, Jabusch HC. Musician's cramp as manifestation of maladaptive brain plasticity: arguments from instrumental differences. Ann N Y Acad Sci. 2012 Apr;1252:259-65. doi: 10.1111/j.1749-6632.2012.06456.x.
Background: PubMed 16924027Schmidt A, Jabusch HC, Altenmuller E, Hagenah J, Bruggemann N, Hedrich K, Saunders-Pullman R, Bressman SB, Kramer PL, Klein C. Dominantly transmitted focal dystonia in families of patients with musician's cramp. Neurology. 2006 Aug 22;67(4):691-3. doi: 10.1212/01.wnl.0000230148.00035.f9.
Background: PubMed 20795373Altenmuller E, Jabusch HC. Focal dystonia in musicians: phenomenology, pathophysiology, triggering factors, and treatment. Med Probl Perform Art. 2010 Mar;25(1):3-9.
Background: PubMed 15668436Schuele S, Jabusch HC, Lederman RJ, Altenmuller E. Botulinum toxin injections in the treatment of musician's dystonia. Neurology. 2005 Jan 25;64(2):341-3. doi: 10.1212/01.WNL.0000149768.36634.92.
Background: PubMed 8929169Pullman SL, Greene P, Fahn S, Pedersen SF. Approach to the treatment of limb disorders with botulinum toxin A. Experience with 187 patients. Arch Neurol. 1996 Jul;53(7):617-24. doi: 10.1001/archneur.1996.00550070055012.
Background: PubMed 23884039Peterson DA, Berque P, Jabusch HC, Altenmuller E, Frucht SJ. Rating scales for musician's dystonia: the state of the art. Neurology. 2013 Aug 6;81(6):589-98. doi: 10.1212/WNL.0b013e31829e6f72. Epub 2013 Jul 24.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steven Frucht, MD principal investigator

NYU Langone Health

David M Simpson, MD principal investigator

Icahn School of Medicine at Mount Sinai

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing incobotulinumtoxin A in people with Dystonia, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physician Global Perception of Change - Blinded Rater 1 (time frame: at visit 4 (week 8)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02107261, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.