OnabotulinumtoxinA in the Management of Psychogenic Dystonia

NCT02618889 | Completed Phase 4

• 1 other identifier: 2015-4496
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to evaluate if patients with psychogenic dystonia treated with onabotulinumtoxinA (BOTOX) injections will demonstrate lower severity and disability at one month and at three months than those having received placebo injections

Conditions

Torticollis, Dystonia

Outcome Measures

Primary Outcomes (1)

• Rating Scale for Psychogenic Movement Disorders (RSPMD)

  Primary outcome measures will be the combined severity, duration factor, and incapacitation scores (investigator-rated) of the Rating Scale for Psychogenic Movement Disorders (RSPMD, 0-12 per each limb and head \[maximum for all five regions: 60\]) (see Appendix 1).

  4 months

Secondary Outcomes (3)

• Clinical Global Impression (CGI) of change

  4 months

• Hamilton Depression Rating Scale (HAM-D)

  4 months

• Hamilton Anxiety Rating Scale (HAM-A)

  4 months

Study Arms (2)

CBT plus botox

ACTIVE COMPARATOR

Participants will be randomized to receive BoNT (onabotulinumtoxinA). Patients will undergo study assessments four weeks later. We will inject a total of 250 units of onabotulinumtoxinA, as the average optimal dose in cervical dystonia,11 using a 100:1 dilution with normal saline. The target muscles will be the ones deemed most active in the cervical region or in any of the affected limbs. If several limbs are affected, only up to two will be targeted in similar fashion, with a total dose not to exceed 400 units altogether (250 +150 units, if involvement is asymmetric or unilateral \[leg and arm, respectively\]; 200 + 200 units, if involvement is symmetric).

Behavioral: CBT

CBT plus placebo

PLACEBO COMPARATOR

Participants will be randomized to receive normal saline (placebo). We will inject a total of 250 units of normal saline, as this is the average optimal dose of onabotulinumtoxinA in cervical dystonia. The target muscles will be the ones deemed most active in the cervical region or in any of the affected limbs. If several limbs are affected, only up to two will be targeted in similar fashion, with a total dose not to exceed 400 units altogether (250 +150 units, if involvement is asymmetric or unilateral \[leg and arm, respectively\]; 200 + 200 units, if involvement is symmetric).

Behavioral: CBT

Interventions

CBT BEHAVIORAL

All participating subjects will start a 12-week CBT treatment program. These consist of weekly 1-hour CBT sessions led by a cognitive therapist. Assessments will be repeated at week 16. All PsyD subjects will undergo a 15-minute, structured diagnostic interview (Mini International Neuropsychiatric Interview (MINI)) developed to screen for axis I DSM-IV and ICD-10 psychiatric disorders. We will also use two clinician-rated instruments to assess comorbid psychopathology in PsyD patients, the 17-item Hamilton Depression Rating Scale (HAM-D), to evaluate for depressed mood, vegetative and cognitive symptoms of depression; and the 14-item Hamilton Anxiety Rating Scale (HAM-A) to evaluate psychic and somatic anxiety. These scales will be administered as part of a structured interview.

CBT plus botox; CBT plus placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet standard criteria for clinically definite PsyD;17
• PsyD severity and disability score ≥ 10 as measured by the RSPMD (Appendix 1);10
• Dystonic posturing must have been present without remission for a period longer than 1 year.
• Between the ages of 18 and 75, inclusive

You may not qualify if:

• Prior treatment with any BoNT
• Presence of clinically unstable medical condition other than the condition under evaluation
• Concurrent participation in another investigational drug or device study within 30 days prior to study enrollment.
• We will also exclude subjects with medical disorders deemed at increased risk when exposed to BoNT, including myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or other neuromuscular disorders.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

Alberto Espay

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Torticollis; Dystonia

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Study Officials

• Alberto Espay, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: December 2, 2015
• Study Start: January 15, 2016
• Primary Completion: May 30, 2017
• Study Completion: June 30, 2017
• Last Updated: November 30, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)