Treatment of whiplash by dopamine
Phase 1
- Conditions
- whiplash tension-type headacheMedDRA version: 21.1Level: LLTClassification code 10047930Term: Whiplash injury to neckSystem Organ Class: 100000004863MedDRA version: 21.1Level: LLTClassification code 10043270Term: Tension headache (excl migraine)System Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2021-003574-31-DK
- Lead Sponsor
- niversity of Copenhagen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
whiplash associated disorder grade 2
tension type headache
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
age < 50 years
no previous whiplash
no other chronic pain condition
no other chronic diseases
pregnancy
no safe contraception
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to relieve neck pain and head ache;Secondary Objective: to improve coordination of head movements;Primary end point(s): relieve of neck pain and headache;Timepoint(s) of evaluation of this end point: prior to treatment<br>1. week pramipexole 0.18 mg<br>2. week pramipexole 0.36 mg<br>3. week pramipexole 0.54 mg<br>A option: To continue treatment for 4 weeks<br>B option: To discontinue treatment and check after 4 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): improve coordination of head movements;Timepoint(s) of evaluation of this end point: prior to treatment<br>1. week pramipexole 0.18 mg<br>2. week pramipexole 0.36 mg<br>3. week pramipexole 0.54 mg<br>A option: To continue treatment for 4 weeks<br>B option: To discontinue treatment and check after 4 weeks